BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4200471 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20367
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    April 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3888-56, LOT# V525986, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6). PRODUCT TYPE EXTENSION, PRODUCT ID 3888-33, LOT# V536164, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3888-56, LOT# V532592, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3888-33, LOT# V536164, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELECTRODES 6 AND 7 HAD HIGH IMPEDANCES WITH VALUES OF GREATER THAN 10,000 OHMS. NO LEAD FRACTURES HAD BEEN FOUND. THE PATIENT¿S DEVICE WAS REPROGRAMMED AROUND THE ELECTRODES WITH HIGH IMPEDANCES ANDNO FURTHER TROUBLESHOOTING WAS NECESSARY. THE PATIENT HAD NOT EXPERIENCED ANY SYMPTOMS RELATED TO THIS EVENT AND WAS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678370 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR